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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Umbilical
510(k) Number K912054
Device Name LABOR DELIVERY TRAY
Applicant
MEDICAL DEVICE INSPECTION CO., INC.
55 NORTHERN BLVD.
SUITE 301
GREAT NECK,  NY  11021
Applicant Contact ALAN P.SCHWARTZ
Correspondent
MEDICAL DEVICE INSPECTION CO., INC.
55 NORTHERN BLVD.
SUITE 301
GREAT NECK,  NY  11021
Correspondent Contact ALAN P.SCHWARTZ
Regulation Number884.4530
Classification Product Code
HFW  
Date Received05/09/1991
Decision Date 01/21/1992
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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